Systems, devices and methods for implantable neuromodulation stimulation

ABSTRACT

The present invention comprises implantable neuromodulation systems and methods comprising a protective pouch that at least partially encases an implantable pulse generator prior to implanting in a patient and is adapted to be secured within the surgical site. The pouch may be secured to a pedicle screw and/or a fixation rod, or to a vertebral body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional of U.S. Non-Provisional patent application Ser. No.16/665,525, filed Oct. 28, 2019 and claims priority to U.S. ProvisionalPatent Application No. 62/752,223, filed Oct. 29, 2018 and titledIMPLANTABLE NEUROMODULATION SYSTEM AND KIT and U.S. Provisional PatentApplication No. 62/793,319, filed Jan. 16, 2019 and titledNEUROMODULATION THERAPIES AND IMPROVED NEUROMODULATION SYSTEMS, thecontents of which are hereby incorporated by reference in theirentirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION Field of the Invention

The invention relates to a system and/or method for treating chronicspinal pain comprising a surgical procedure combining a spinal proceduresuch as vertebral fusion with implantation of a neuromodulation device,wherein the surgical procedure is conducted with open physical andvisual access to the region of the spine undergoing treatment.

Description of the Related Art

A neuromodulation procedure in accordance with the present invention isperformed at a spinal treatment site. The neuromodulation procedureincludes the placement of one or more neurostimulation leads at one ormore target spinal levels, and more specifically, at the dorsal rootganglia at each of the target spinal levels.

The neurostimulation leads include a distal portion having one or moreelectrodes positioned at the distal portion, the neurostimulation leadsfurther having a proximal portion capable of coupling to an implantablepulse generator. The neurostimulation lead further includes one or moreelectrically conductive wires capable of receiving an electrical signalin a distal portion, when electrically coupled to a pulse generator. Theneurostimulation leads, when coupled to an implantable pulse generator,are then capable of delivering an electrical signal via the electrodesto a target site, such as a target dorsal root ganglia.

The procedure for placing of the neurostimulation leads may includeplacing the distal segment of one or more neurostimulation leads at thecorresponding one or more target dorsal root ganglia such that the oneor more electrodes of the neurostimulation lead is in therapeuticproximity to the target dorsal root ganglia such that when theneurostimulation lead is coupled to an implantable pulse generator andan electrical signal is delivered to the target dorsal root ganglia viathe implantable pulse generator such electrical signal results inneuromodulation of the target dorsal root ganglia.

The neuromodulation procedure may further include routing of theproximal portion of the neurostimulation lead to the implantable pulsegenerator. The implantable pulse generator may be placed during thespinal procedure in an anatomical location that is dependent upon theparticular treatment procedure performed or dependent upon physicianpreference or dependent upon patient preference or some combinationthereof.

Once the implantable pulse generator has been electrically coupled tothe leads, the pulse generator can be activated to deliver, via the oneor more neurostimulation leads, a neuromodulation therapy to the spinaltreatment site.

Anchoring and/or securing the implantable pulse generator within thesurgical site would be advantageous.

Anchoring and/or securing the electrical lead(s) along at least part oftheir length would be advantageous.

Providing an electrical lead placement tool to facilitate translationand placement of the electrode at the site of interest, e.g., intherapeutic proximity to a dorsal root ganglion, would be advantageous.

The Figures and the Detailed Description which follow more particularlyexemplify these and other embodiments of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1A is a view of one embodiment of the present invention.

FIG. 1B is a view of the embodiment of FIG. 1A implanted into apatient's anatomy.

FIG. 1C is a view of the embodiment of FIG. 1A implanted into apatient's anatomy.

FIG. 1D is a view of the embodiment of FIG. 1A implanted into apatient's anatomy.

FIG. 1E is a perspective view of one embodiment of the presentinvention.

FIG. 2 is a top view of one embodiment of the present invention.

FIG. 3A is a top view of one embodiment of the present invention.

FIG. 3B is a top view of one embodiment of the present invention.

FIG. 4 is a top view of one embodiment of the present invention.

FIG. 5A is a top view of one embodiment of the present invention.

FIG. 5B is a side view of the embodiment of FIG. 5A.

FIG. 6A is a top view of one embodiment of the present invention.

FIG. 6B is a side view of the embodiment of FIG. 6A.

FIG. 7A is a side view of one embodiment of the present invention.

FIG. 7B is a top view of the embodiment of FIG. 7A.

FIG. 7C is a side view of one embodiment of the present invention.

FIG. 7D is a perspective view of one embodiment of the presentinvention.

FIG. 7E is a side view of one embodiment of the present invention.

FIG. 7F is a perspective view of one embodiment of the presentinvention.

FIG. 7G is a perspective view of one embodiment of the presentinvention.

FIG. 8 is a side view of one embodiment of the present invention.

FIG. 9A is a top view of one embodiment of the present invention.

FIG. 9B is a top view of one embodiment of the present invention.

FIG. 10A is a fluoroscopic image of one embodiment of the presentinvention.

FIG. 10B is a fluoroscopic image of one embodiment of the presentinvention.

FIG. 11 is a top view of one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a system and kit for improving andenhancing the implantation of a neuromodulation device alone or incombination with a spinal fixation or other spinal treatment procedure.The present invention further provides a system and kit for placing andanchoring the implantable pulse generator and leads at a spinaltreatment site. The present invention provides embodiments for a pouchfor encasing an implantable pulse generator. The pouch having one ormore attachment members for anchoring, tethering or fixating the pouchto a target anchor site. The pouch encasing the implantable pulsegenerator is adapted to be secured within the surgical site. The pouchmay be secured to a pedicle screw and/or a fixation rod, or to avertebral body.

Various embodiments of the present invention may be implemented withimplantation of a neuromodulation device or system, either alone or incombination with a spinal fixation or other spinal treatment procedurewithin a surgical site.

FIG. 1A illustrates an implantable pulse generator (IPG) 2 withelectrical leads 6 attached thereto. The IPG is at least partiallyenclosed in a pouch 100 and the leads 6 extend through the pouch 100 tothe site of interest. The pouch 100 includes pouch walls W1, W2, W3and/or W4, and/or W5, and/or W6 that may be defined relative to theimplantable pulse generator 2. The pouch 100 includes first and secondopposing walls W1 and W2, respectively, corresponding to the two majorsurfaces of the implantable pulse generator 2. The pouch 100 furtherincludes one or more side-walls including any of walls W3-W6 extendingbetween the two major surfaces and connecting the two opposing majorsurfaces W1 and W2 to each other. FIG. 1E provides an exemplaryembodiment for pouch 100.

The pouch 100 walls W1-W6 may enclose all or only a portion of thecorresponding side of the implantable pulse generator. As the skilledartisan will readily recognize, one or more of the side walls W3-W6 maybe eliminated, wherein the major surface walls W1 and W2 are connectedor integrated with each other directly. In the most extreme embodiment,Walls W1 and W2 are the only surfaces required. A sealable opening maybe provided along one of the walls W1-W6 to allow insertion of the IPG 2into the pouches interior defined by walls and then the opening may besealed closed with the IPG 2 sealed inside.

One or more of pouch walls W1-W6 may further include one or moreapertures A or discontinuities, including an aperture for allowing leadsto extend through the pouch 100 wall and couple to the implantable pulsegenerator 2. Additional apertures A and discontinuities may be definedby the pouch wall in accordance with design preferences, functionalbenefits and application requirements. For example, without limitation,one or more apertures A or discontinuities may be incorporated into oneor more pouch walls in order to allow tissue to anchor to the pouch whenimplanted in a patient's anatomy.

Alternatively, a continuous planar surface may be intentionally used onat least a portion of the pouch 100 to minimize tissue growth into, onor near that section of the pouch 1. As yet another alternative, one ormore wall may be defined only by a narrow strip of pouch 100 materialextending across a larger corresponding surface of the implantable pulsegenerator 2.

The pouch 100 has an interior space I defined by the pouch 100 walls W1,W2 and/or W3-W6, whether or not such pouch walls include one or moreapertures A or discontinuities. The interior space defines a plenum forreceiving an implantable pulse generator.

The interior space I may be dimensioned such that each wall W1, W2and/or W3-W6 of the pouch 100 is in direct contact with a correspondingsurface the implantable pulse generator 2 providing a snug fit aroundthe IPG 2. Alternatively, only one or less then all of the interiorsurfaces of walls W1, W2 and/or W3-W6 of the pouch 100 may be in directcontact with the corresponding nearest surface of the implantable pulsegenerator 2, or such that only a portion of a given interior wallsurface of the pouch 100 is in contact with a corresponding surface ofthe implantable pulse generator 2 to provide a loose fit.

The pouch 100 is made of a biocompatible material, such as medical gradesilicone or other medical grade thermoplastic polymers capable of beingimplanted in a human anatomy. The properties of the pouch 100 mayinclude a flexible, rubber-like attribute such that it is slightly tomoderately deformable yet sufficiently rigid to maintain its generalpouch shape. Suitable materials may include, but are not limited to,silicone rubber manufactured by Simtec at 9658 Premier Parkway, Miramar,Fla.

The pouch 100 may further be coated or impregnated with one or morechemicals or materials having additional biological and/or physiologicalactivities or characteristics. Such attributes may include but are notlimited to: antimicrobial, antifungal, antibiotic, anti-infection,analgesic properties, drug-eluting, tissue growth inhibiting, tissuegrowth enhancing, and combinations thereof.

The pouch 100, in accordance with the present invention, may bemanufactured in various dimensions in order to define an interiorsurface capable of receiving an implantable pulse generator 2 havingcomplimentary dimensions. There are many implantable pulse generatorswith varying dimensions and as such a pouch 100 may be dimensioned tothe specific dimensions of a specific implantable pulse generator 2 orthe pouch 100 may be dimensioned to approximately enclose a wide rangeof implantable pulse generators. Alternatively, the pouch 100 may beadjustable along one or more dimensions in order to accommodateimplantable pulse generators of different dimensions.

As shown in FIGS. 1B-1D, the pouch 100 may be used in conjunction withan implantable pulse generator 2 implanted to provide a neuromodulationtherapy to one or more target dorsal root ganglia. Such an implantablepulse generator 2 may be substantially smaller in size than implantablepulse generators traditionally used in spinal cord stimulation.Specifically, the implantable pulse generator 2 shown in FIGS. 1B-1D mayhave a volume of 11 cubic centimeters, or between 3 cubic centimetersand 10 cubic centimeters, or between 1 cubic centimeters and 3 cubiccentimeters, or less than 1 cubic centimeter. As such, the pouch 100 maybe dimensioned such that an interior surface defines a shape and volumecorresponding to that of the implantable pulse generator 2.

As shown in FIG. 1B, an implantable pulse generator 2 may be receivedwithin a pouch 100 and the combination results in a pouch-encasedimplantable pulse generator 2, or at least partially encased or enclosedwithin the pouch 100. The pouch-encased implantable pulse generator 2may be implanted in the tissue of the patient anatomy located at theflank as generally shown in FIG. 1B. As described, the implantable pulsegenerator 2 may be completely or partially enclosed or encased withinpouch 100.

As shown in FIG. 1C, a pouch-encased implantable pulse generator 2 maybe implanted along the spine 7 of a patient anatomy. The pouch-encasedimplantable pulse generator 2 may be implanted at a section of thepatient anatomy where bone has been removed from the spinal treatmentsite, or it may be implanted next to, at, or near an existing spinalprocess of the patient anatomy.

As shown in FIG. 1D, a pouch 100 encased implantable pulse generator 2may be implanted remotely from a spinal treatment site. A junction box 8may, in some embodiments, be implanted at or near the spinal treatmentsite and leads extend from the junction box 8 to the remotely positionedpouch 100 encased implantable pulse generator 2. Alternatively, junctionbox 8 may be operatively electrically connected with IPG 2 with leads 6extending from junction box 8 to the site of interest, e.g., a dorsalroot ganglion.

The pouch-encased implantable pulse generator 2 may be implanted by avariety of methods and sequences. The pouch-encased implantable pulsegenerator 2 may be implanted during and in combination with an open backspinal fixation, or other spinal, procedure, prior to or after suchspinal procedure has been completed, as a procedure independent of aspinal procedure, as a minimally invasive procedure and/or as part of arevision procedure.

FIG. 2 shows an implantable pulse generator 2 encased in a pouch 100 asdescribed above and implanted over the spine 7 of a patient anatomy at aspinal treatment site. The implantable pulse generator 2 is dimensionedsuch that it is positioned at a spinal treatment site between a pair ofspinal fixation rods 4 for fixing relative motion between affectedvertebrae. The implantable pulse generator 2 may be positioned betweentwo existing spinous processes or in the bone removed portion of aspinal treatment site.

The pouch 100 at least partially encasing the implantable pulsegenerator 2 may include one or more attachment elements for anchoringthe pouch 100 to a corresponding one or more spinal fixation rods 4. Theattachment elements in the present embodiment may comprise non-rigidlooped attachment members 3 that extend from the pouch 100 to a remotelypositioned pedicle screw 5. The non-rigid looped attachment members 3comprise a flexible medical grade material having elastic rubber-bandlike properties such that the attachment members provide a releasabletension that allows for connecting of the pouch 100 to the pedicle screw5 by looping a portion of the attachment member around the pedicle screw5.

When the non-rigid looped attachment members 3 are operatively connectedto and/or looped around the pedicle screw 5, the pouch 100 is maintainedin a tethered relationship to the pedicle screw 5 by the tension in theportion of the non-rigid looped attachment member 3 extending from thepedicle screw 5 to the pouch 100. The pouch 100 may be attached to twoseparate pedicle screws 5 via separate attachment members 3 or separateportions of a single tension member such that it is maintained inrelative position to the spinal fixation rods 4.

FIGS. 3A and 3B show an implantable pulse generator 2 at least partiallyencased in a pouch 100 as described above and positioned between a pairof spinal fixation rods 4. The pouch may include one or more attachmentelements or tethers 9 extending from a first end, or a wall W1-W6 asshown in FIG. 1E, at the pouch 100 to a second end, or a wall W1-W6,coupled to a spinal fixation rod 4. The second end of the attachmentelement or tether 9 may be coupled to the spinal fixation rod 4 with agrip 10 for maintaining a connection between the second end of theattachment element or tether 9 and the corresponding spinal fixation rod4.

In FIG. 3A a first single grip 10 is shown attached to a singlecorresponding first fixation rod 4, two attachment members or tethers 9extend from a first end at the pouch 100 to a second end at the firstsingle grip 10 to tether the pouch 100 to the first fixation rod 4.

A second single grip 10 is shown attached to a single correspondingsecond fixation rod 4. Two attachment members or tethers 9 extend from afirst end at the pouch 100 to a second end at the second single grip totether the pouch 100 to the second fixation rod 4.

In FIG. 3B, four separate attachment members or tethers 9 are shown,each extending from a first end at the pouch 100 to a second end at acorresponding grip 10 to couple the pouch 100 to the corresponding firstand second fixation rods 4 in a generally X-type relationship.

The attachment elements or tethers 9 in FIGS. 3A and 3B may be flexibleand elastic in performance so as to maintain a tension between the firstand second end of the attachment member or tether 9 when extendingbetween the pouch 100 and grips 10.

Alternatively, the attachment members or tethers 9 may be non-flexibleor minimally flexible and merely tether the pouch 100 to the fixationrod 4 without providing tension therebetween.

Whether the attachment elements or tethers 9 are flexible/elastic or nonto minimally flexible, the pouch 100, and encased implantable pulsegenerator 2, will be anchored between the fixation rods 4 but will beable to float within a predetermined volume of space to a greater orlesser extend depending upon the flexibility and slack of the attachmentelements or tethers 9.

FIG. 4 illustrates an implantable pulse generator 2 encased in a pouch100 as described above. The pouch-encased implantable pulse generator 2may be positionable next to the vertebral body of a spinal treatmentsite as shown, or between adjacent vertebral bodies of a spinaltreatment site. One or more attachment elements or tethers 9 asdescribed above are shown having a first end extending from the pouch100 and a second end extending to a grip 10, also as described above.However, in this embodiment, the attachment elements or tethers 9provide a tethered fixation of the pouch 100 to a portion of a vertebralbody, instead of a fixation rod 4, by grip 10 coupled to the second endof the attachment element 9. The attachment elements or tethers 9, whenengaged with a vertebral body by corresponding grips 10, maintain thepouch 100 encased implantable pulse generator 2 in a tetheredrelationship with respect to the vertebral body. This feature alsoallows our implantable pulse generator device to be implanted andfixated by a surgeon independent of any spinal fixation components. Thiscould also be delivered and fixated by way of a minimally invasivespinal surgical approach.

FIGS. 5A-5B illustrate a pouch 100 encased implantable pulse generator 2wherein the pouch 100 includes an attachment surface 18 extending from aportion of the pouch 100 for attaching the pouch 100 to a pedicle screw5. The attachment surface 18 may comprise one or more contoured sidewalls configured to mate with a corresponding receiving wall of thepedicle screw 5 head. The connecting element further includes acontoured end wall configured to engage a portion of a fixation rod 4.The attachment surface 18 shown in FIGS. 5A and 5B maintains the pouch100 encased implantable pulse generator 2 in a fixed relationship withrespect to the pedicle screw 5 to which it is attached.

FIGS. 6A-6B illustrate a pouch 100 encased implantable pulse generator 2wherein the pouch 100 includes an attachment member 20 extending from aportion of the pouch body for attaching the pouch to a fixation rod. Theattachment member 20 includes an outwardly extending connecting elementhaving a contoured and/or complementary engagement surface for engagingthe outer surface of a fixation rod 4. The attachment member 20 shown inFIGS. 6A and 6B maintains the pouch 100 encased implantable pulsegenerator 2 in a fixed relationship with respect to the fixation rod 4to which it is attached.

FIGS. 1A through 6B relate to implantation and fixation of theimplantable pulse generator 2 using a pouch 100 for encasing theimplantable pulse generator 2 and one or more attachment elements orsurfaces for fixating the pouch 100 encased implantable pulse generator2 within a patient's anatomy.

FIGS. 7-9 relate to lead placement and fixation in a patient anatomy.

FIGS. 7A-7C illustrate a lead placement tool 200. The lead placementtool 200 comprises first and second end regions, 202, 204 and a centralregion 206 extending therebetween, and a top surface T and a bottomsurface B extending along first and second regions 202, 204 and centralregion 206. The first end region 202 of the lead placement tool 11 mayhave an angle α, as shown about a 90-degree bend, with respect to thecentral portion 206 of the tool 200. The first end region 202 of thelead placement tool 200 may comprise a portion that is curved to createa groove or channel 208 that is open for slideably receiving a lead 6therein. The first end 202 of the lead placement tool 200 further has abottom surface B for slideably advancing and retracting the leadplacement tool 200 against a bone or other anatomical space. FIG. 7Cshows an exemplary groove or channel 208 with electrical lead receivedtherein. As will be discussed below, first or second regions 202, 204may be straight, without a bend relative to the central region 106.

As shown, and in all embodiments, the first and second regions, 202, 204and the central region 206 of the lead placement tool 200 all extendalong a common longitudinal plane, whether angles exist or not. In otherwords, the first and second regions 202, 204 and the central region 206are collinear and coplanar.

The groove or channel 208 may be provided alone one or both of first andsecond end regions 202, 204. Further, the groove or channel 208 may bedisposed so that is it open along the top surface of one or both offirst and second end regions 202, 204 and/or open along the bottomsurface of one or both of first and second end regions 202, 204.

As shown in more detail in FIG. 7B, the first end region 202 of the leadplacement tool 202 is positioned in an anatomical space such that thebottom surface B of the lead placement tool 200 interfaces with the boneand the top surface of the first end region of the tool 200 provides theopen groove or channel 208 for slideably advancing the lead 6 forplacement at an anatomical site such as the dorsal root ganglia or intherapeutic proximity to the dorsal root ganglia or other nerve target.Once the lead 6 has been placed in therapeutic proximity to the dorsalroot ganglia or other nerve target, the lead placement tool 200 can thenbe slideably retracted, leaving the lead 6 in place.

The second end region of the lead placement tool 11, as shown in FIG.7A, may have an angle β with respect to the axis of the central region206 of the tool 200, creating an exemplary angle of about 45 degreesbetween the second end region 204 and the central region 206. The secondend region of the tool 11 may have a curved open portion creating agroove or channel 208 similar to that of the first end region 202. Thegroove or channel 208 when present in either first or second end regions202, 204 may be formed along the top surface T of tool 200, the bottomsurface B of tool 200. The first end region 202 may comprise the grooveor channel 208 along its top surface T or its bottom surface B and thesecond end region 204 may comprise the groove or channel 208 along itstop surface or its bottom surface B.

In all cases, the surface of the tool 200 that is opposite of the opengroove or channel 208 is curved, closed and relatively smooth to allowthat portion of the tool 200 to slide along bone or other anatomicalstructure.

In some cases only a single angle and groove or channel 208 may beprovided. In other embodiments, two angles and two grooves or channels208 are provided.

The second end region 204 of the tool 200 functions in the same manneras described above with respect to the first end of the tool 200. Theangles α and β may be the same or they may differ. Depending on patientanatomy and/or the preference of the physician performing the leadplacement procedure, the first end region 202 or the second end region204 of the tool 200 may be the more preferable and/or more effectiveguide for lead placement in a given procedure or procedure step.

It is intended that the 90-degree bend and 45-degree bend described withrespect to the first end region 202 and second end region 204,respectively, are merely exemplary, and that many different bend anglesare contemplated in accordance with the present invention even extendingas far as a straight tool with a zero-degree bend, and including ashallow bend tool 200 with at least one end region having a less than45-degree bend with respect to the axis of the central region 206 of thetool 200

FIGS. 7D-7G illustrate an alternative embodiment of a lead placementtool 200. The tool 11 has opposing first and second end regions 202, 204and a central region 206 extending therebetween. The first end region202 of the lead placement tool 200 comprises angle α that is shown abouta 90-degree bend with respect to the central region 200 of the tool 200.

The first and second end regions 202, 204 of the lead placement tool 200has top surface T curved to create a groove or open channel 208 forslideably receiving a lead 6 therein. As noted, alternative embodimentsmay comprise groove or open channel 208 formed along the bottom surfaceB of tool 200.

As best shown in FIGS. 7E-7G, open channel 208 may extend beyond eitherthe first end or second end regions 202, 204 and may extend along a topT or bottom B surface of the central region 206 in certain embodiments.

Returning to FIGS. 7D-7G, once the lead 6 has been placed in therapeuticproximity to the dorsal root ganglia or other nerve target, the leadplacement tool 200 can then be slideably retracted, leaving the lead 6in place at or near the nerve target.

Depending on patient anatomy and/or the preference of the physicianperforming the lead placement procedure, the first end or the second endregions 202, 204 of the lead placement tool 200 may be the morepreferable and/or more effective guide for lead placement in a givenprocedure or procedure step. It is intended that the illustrated90-degree bend and 45-degree bend for angles α and/or β are merelyexemplary, and that many different bend angles are contemplated inaccordance with the present invention even extending as far as astraight tool 200 with a zero-degree angle between the first or secondend region and the central region, and further includes a shallow angleembodiment with at least one of the first or second regions having aless than 45-degree bend with respect to central region of the tool 200.

FIG. 8 illustrates a lead harness 300 having a first side for receivingone a portion of one or more leads 6 thereon. The lead harness 300 isflexibly foldable such that the first side forms a channel for slideablymaintaining the portion of the leads 6 therein. The second side of thelead harness 12 forms a protective cover over the portion of the leads 6maintained within the channel formed by the first side.

The harness 300 further includes an attachment member 9 having a firstend connected to and extending from the harness 300 and a second endextending to and connectable to an anchor location. The anchor locationmay be a fixation rod 4 as shown in FIG. 8 or may be a bone or tissue ora pedicle screw 5 or any other element that would be sufficient tomaintain position of the attachment member 9. The attachment member 9may be a flexible material such that it forms a tethered relationshipbetween the anchor location and the harness 300, providing some degreeof movement to the harness 300 but only within a tethered area definedby the attachment element 9.

The second end of the attachment member 9 may be connected to thefixation rod 4 by wrapping the second end of the attachment member 9around the fixation rod 4 and/or tying the second end to the fixationrod 4. Any number of attachment mechanisms may be used in combinationwith the attachment member 9 to connect the attachment member 9 to ananchor site include a suture, a twist tie, a gripper, a coil and othersuch attachment mechanisms.

The harness 300 provides the advantage of maintaining the placement andpositioning of the leads 6 with respect to each other without providinga gripping force that could be damaging to the lead body and that couldpotentially lead to loss of performance or functionality of the lead 6.

The harness 300 and harness attachment member 9 in combination with thepouch 100 and pouch attachment member 9, and the various embodiments ofthese, provide a means for maintaining the positioning of theimplantable pulse generator 2 and the leads 6 in anatomical positionsthat allow for the ongoing delivery of neuromodulation therapy.

FIGS. 9A and 9B provide example embodiments of the lead placement andlead harness 12 of a neuromodulation system implanted in a patientanatomy in accordance with the present invention.

FIG. 9A shows a series of leads 6 placed such that a distal end of eachlead is positioned in therapeutic proximity to a corresponding dorsalroot ganglion, each lead 6 at a different nerve level. The proximal endof each lead 6 converges such that the proximal end of each lead 6 isreceived in the lead harness 300 resulting in a unilateral arrangementof the leads 6 and lead harness 300.

FIG. 9B illustrates a bilateral arrangement of leads 6 and correspondinglead harnesses 300. A first set of leads 6 each have distal ends on asingle side of a patient spine 7, each lead 6 being placed at adifferent nerve level in therapeutic proximity to a corresponding dorsalroot ganglia. The proximal portions of the first set of leads 6 crossthe spinal axis and converge to enter a lead harness 300 on the oppositeside of the spinal axis A. A second set of leads 6 is in a mirroredrelationship to the first set of leads 6, each of the second set ofleads 6 having a distal end positioned at a different nerve level,placed in therapeutic proximity to a corresponding dorsal root ganglia.The proximal end of each of the second set of leads 6 crossing thespinal axis A and converging to enter a lead harness 300 on the oppositeside of the spinal axis A. This bilateral arrangement of lead placementwith respect to lead harness 300 positioning may provide additional leadplacement stability by minimizing the bending forces on the distal endsof the lead 6 while the harness 300 provides additional lead fixationsupport.

Both FIGS. 9A and 9B provide the lead placement and a spinal fixationdevice with fixation rods 4 and pedicle screws 5.

FIGS. 10A-10B are fluoroscopic images of leads 200 implanted at a spinaltreatment site in combination with a spinal fixation implant. FIG. 10Ashows a spinal treatment site where the spinous process bones have beenremoved during implant of the spinal fixation device. The leads 6 weredelivered from a medial (over the spinal cord dura) to lateral pathwayapproach through to the spinal foramen and the treatment site at theDRG. As shown, the leads 6 enter medially and then flare out to opposingfirst or second lateral sides, loop around a portion of the spinalfixation device and extend to a neuromodulation target at an oppositefirst or second lateral side of the treatment site such that each lead 6is in therapeutic proximity to a corresponding dorsal root ganglia. Byway of example, lead enters medially and extends to a first lateral sideL1, loops around a portion of the spinal fixation device on the firstlateral side L1 and then crosses to the opposing second lateral side L2for placement in therapeutic proximity to the target dorsal rootganglia.

FIG. 10B shows a spinal treatment site where the bone has been removedduring implant of the spinal fixation device. The leads extend from asingle unilateral approach at a spinal level below the fixation device.The leads are then placed along a pathway 301, 302, 303 such that leadsplaced on unilateral approach side are curved around an opposing lateralside of the fixation device and back across the spinal treatment site toa corresponding target dorsal root ganglia. The leads placed on theopposing lateral side are curved around a portion of the fixation deviceon the unilateral approach side before extending laterally to theopposing lateral side via pathway 401, 402.

The lead placement tool 200 described herein can be used, by way ofexample, for placement and anchoring of leads in accordance with thelead pathways shown in FIGS. 10A-10B and with any other such leadpathway as determined by such factors that may include but are notlimited to patient anatomy, bone structure, whether bone has beenremoved, physician preference, lead properties, position of theimplantable pulse generator and other considerations.

The lead harness 300 can be used, by way of example, at the locationwhere a single lead may require anchoring to ensure that a therapeuticrelationship is maintained between the lead and the target nerve. Thelead harness 300 may additionally be used, by way of example but notlimiting other uses, at a location where two or more leads converge suchas shown in FIGS. 10A-10B.

FIG. 11 illustrates an embodiment of a neuromodulation system includingan implantable pulse generator 2 and one or more neurostimulation leads6 coupled to the implantable pulse generator 2. The neuromodulationsystem 13 is implanted at a spinal treatment site where a spinalprocedure has been performed including a decompression procedure and/orincluding a spinal fixation procedure. As shown in FIG. 11, theneuromodulation system is implantable in combination with a spinalfixation procedure including one or more spinal fixation rods 4 securedto the spinal treatment site by pedicle screws 5. The implantable pulsegenerator 2 and leads of the neuromodulation system 13 may incorporateany of the previously described features and elements, or variationsthereof, as described above, including but not limited to a pouch 100,various attachment elements coupled to the pouch 100 to anchor or securethe pouch-enclosed IPG, and may incorporate a lead harness 300.

As shown in FIG. 11, the lead 6 is positioned along the spinal cord toprovide a neurostimulation signal to the spinal cord. The lead 6 extendsfrom the spinal treatment site at a portion of the spinal treatment sitewhere the spinal cord was exposed during a spinal treatment procedure.The lead 6 is positioned along a lead pathway that extends to at least aportion of the thoracic spine, under the intact spinous process of theportion of the thoracic spine. The lead 6 may be incorporate a spinalcord stimulation paddle lead design having one or more programmableelectrodes for optimization of spinal cord stimulation.

Although not shown in FIG. 11, one or more leads 6 may additionallyextend from the implantable pulse generator 2 to one or more targetdorsal root ganglia in accordance with the various lead pathwayspreviously described above.

Another method for implanting a neuromodulation system incorporatedherein is a lateral approach to neurostimulation. Neuromodulation anddelivering electrical or other forms of energy have been typicallyperformed from the dorsal aspect of the spinal cord. Another approachhas been through the neuroforamena and the dorsal root ganglion.

There are many pathways including but not limited to spinothalamic tractthat run in the anterolateral and anterior part of the spinal cord.These nerve fibers and tracts carry a variety of information includingpain signals to more central locations and the brain. Performing spinalcord stimulation from a lateral and/or anterolateral and anteriorapproach has been anatomically and practically challenging. Current leaddesigns and placement techniques may also cause sensation of pain by thepatient.

The improved method for lateral placement of a lead 6 incorporates alead 6 that will be placed in the lateral and/or anterolateral and/oranterior part of the epidural space in the thoracic and/or lumbar and/orcervical region to deliver electrical energy using a variety offrequencies including but not limited to high frequencies and a varietyof complex stimulation patterns.

Other modes of neuro-modulation including pulsed radiofrequency, coolingor gentle heat may also be applied with this approach. Theelectrode/electrodes may also collect a variety of data and biometricsas well as delivering energy. For example cordotomy has been used inextreme refractory cases of cancer pain in the past. It includeslesioning the spinothalamic tract which produces pain relief withsignificant side effects, namely dysesthesias, apnoea and urinaryretention. Placing an anterior lead could be an attempt to modulate andnot destroy these nerve fibers and achieve the relief without theseserious side effects.

The description of the invention and is as set forth herein isillustrative and is not intended to limit the scope of the invention.Features of various embodiments may be combined with other embodimentswithin the contemplation of this invention. Variations and modificationsof the embodiments disclosed herein are possible and practicalalternatives to and equivalents of the various elements of theembodiments would be understood to those of ordinary skill in the artupon study of this patent document. These and other variations andmodifications of the embodiments disclosed herein may be made withoutdeparting from the scope and spirit of the invention.

1. A pouch for at least partially encasing an implantable pulsegenerator (“IPG”) for implantation within a surgical site, the pouchcomprising: opposing first and second major surface walls; wherein theopposing first and second major surface walls define an interior plenumthat is configured to receive and at least partially enclose the IPGtherein, wherein the pouch is adapted to be secured within the surgicalsite; one or more apertures or discontinuities in the pouch sized andadapted to allow at least one electrical lead operatively connected tothe IPG to pass through the pouch; and an attachment surface extendingfrom the pouch, the attachment surface adapted for attaching the pouchto a pedical screw disposed within the surgical site.
 2. The pouch ofclaim 2, wherein the pedicle screw comprises a pedicle screw headdefining at least one receiving wall, and wherein the attachment surfacecomprises at least one side wall adapted to engage a correspondingreceiving wall of the pedicle screw head.
 3. The pouch of claim 2,wherein the IPG is at least partially encased within the pouch andwherein the attachment surface is adapted to maintain the IPG and thepouch in a fixed relationship with respect to the pedicle screw.
 4. Thepouch of claim 3, further comprising a connecting element configured toengage a portion of a fixation rod.
 5. The pouch of claim 4, wherein theportion of the connecting element that engages a portion of the fixationrod further comprises a contoured end wall.
 6. The pouch of claim 1,further comprising at least one additional wall disposed between thefirst and second major surface walls.
 7. The pouch of claim 1, whereinthe pouch is coated or impregnated with at least one material having oneor more of the properties of the group consisting of antimicrobial,antifungal, antibiotic, anti-infection, analgesic properties,drug-eluting, tissue growth inhibiting, and tissue growth enhancing. 8.A pouch for at least partially encasing an implantable pulse generator(“IPG”) for implantation within a surgical site, the pouch comprising:opposing first and second major surface walls; wherein the opposingfirst and second major surface walls define an interior plenum that isconfigured to receive and at least partially enclose the IPG therein,wherein the pouch is adapted to be secured within the surgical site; oneor more apertures or discontinuities in the pouch sized and adapted toallow at least one electrical lead operatively connected to the IPG topass through the pouch; and an attachment member extending from aportion of the pouch adapted to engage a fixation rod.
 9. The pouch ofclaim 8, further comprising an outwardly extending connecting elementadapted to engage the fixation rod.
 10. The pouch of claim 9, whereinthe outwardly extending connecting element comprises a contouredengagement surface for engaging the outer surface of the fixation rod.11. The pouch of claim 10, wherein the contoured engagement surfacecomprises a complementary shape with respect to the outer surface of thefixation rod.
 12. The pouch of claim 8, wherein the attachment member isadapted to maintain the pouch in a fixed relationship with the fixationrod.
 13. The pouch of claim 8, wherein the pouch is coated orimpregnated with at least one material having one or more of theproperties of the group consisting of antimicrobial, antifungal,antibiotic, anti-infection, analgesic properties, drug-eluting, tissuegrowth inhibiting, and tissue growth enhancing.
 14. A method fortreating pain generated by a patient's spinal column in a combinedprocedure using vertebral stabilization and neuromodulation stimulation,comprising: identifying two or more targeted vertebral levels forvertebral stabilization; identifying one or more targeted spinal levelsfor neuromodulation stimulation, including at least one targeted dorsalroot ganglion; creating an open access into the resulting spinaltreatment site to provide direct visual access to the identifiedtargeted vertebral levels and the at least one identified targetedspinal level and the at least one targeted dorsal root ganglion;stabilizing the identified vertebral levels; and placing aneuromodulation system comprising: an implantable pulse generator,wherein the implantable pulse generator is at least partially enclosedwithin a biocompatible pouch, wherein the biocompatible pouch is securedwithin the spinal treatment site, at least one electrical lead inoperative electrical communication with the implantable pulse generator,wherein the at least one electrical lead is routed from the implantablepulse generator through at least one aperture in the biocompatible pouchto a location within therapeutic proximity of the at least one targeteddorsal root ganglion at each of the one or more target spinal levels,and at least one electrode disposed at a distal end of the at least oneelectrical lead, wherein the at least one electrode is placed intherapeutic proximity with each of the at least one targeted dorsal rootganglion at each of the one or more target spinal levels; and closingthe open access.
 15. The method of claim 13, wherein the stabilizing ofthe identified vertebral levels comprises securing the identifiedvertebral levels with two bilaterally spaced apart fixation rods,wherein each fixation rod is secured to vertebral bone with two or morepedicle screws; and securing the biocompatible pouch to at least one ofthe group consisting of: a pedicle screw, a fixation rod, and avertebral body.
 16. A method for treating pain generated by a patient'sspinal column in a combined procedure using neuromodulation stimulation,comprising: identifying one or more targeted spinal levels forneuromodulation stimulation, including at least one targeted dorsal rootganglion; creating an open access into the resulting spinal treatmentsite to provide direct visual access to the at least one identifiedtargeted spinal level and the at least one targeted dorsal rootganglion; placing a neuromodulation system comprising: an implantablepulse generator, wherein the implantable pulse generator is at leastpartially enclosed within a biocompatible pouch, wherein thebiocompatible pouch is secured within the spinal treatment site, atleast one electrical lead in operative electrical communication with theimplantable pulse generator, wherein the at least one electrical lead isrouted from the implantable pulse generator through at least oneaperture in the biocompatible pouch to a location within therapeuticproximity of the at least one targeted dorsal root ganglion at each ofthe one or more target spinal levels, and at least one electrodedisposed at a distal end of the at least one electrical lead, whereinthe at least one electrode is placed in therapeutic proximity with eachof the at least one targeted dorsal root ganglion at each of the one ormore target spinal levels; and closing the open access.